Webinar on Calibration and Qualification in Analytical Laboratories

MessageThis Webinar is over
Date Jun 10, 2014
Time 10:00am
Cost $245.00
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.

For easy implementation, attendees will receive:
  • 4 SOPs
    • User Requirement Specifications (URS) for analytical equipment
    • Change control for analytical equipment
    • Qualification of equipment
    • Allocating Analytical Instruments to USP <1058> Categories
  • 20+ Examples for Instrument OQ Testing

Areas Covered in the Session:
  • Operational lab equipment requirements for calibration and qualification
  • Most common inspection problems
  • USP Chapter <1058>: Analytical Instrument Qualification
  • Development of an effective equipment qualification master plan
  • Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Allocating equipment to qualification categories A, B and C
  • Qualification and documentation requirements for each category
  • Going through the category example list
  • Approach for existing systems
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Documentation requirements
Who Will Benefit:
  • QA Managers and Personnel
  • Analysts and lab Managers
  • Analysts
  • QA Managers and Personnel
  • Regulatory affairs
  • Training Departments
  • Documentation department
  • Consultant
Quick Contact:

USA Phone:800-447-9407
Event Link - http://bit.ly/1rla55u


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